Kilo and Pilot Scale API

Services CMC Kilo and Pilot Scale API

Supporting the transition from process development to GMP API manufacturing with flexible kilo lab and pilot-scale production.

Scaling a process from the laboratory into manufacturing is a critical step in drug substance development. BioDuro’s kilo lab and pilot-scale capabilities support process evaluation, material generation, technology transfer, and preparation for GMP production.

Programs can be supported with non-GMP material for development and GLP toxicology studies, as well as GMP API for early clinical use.

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From Process Development to GMP Production

Moving a process into clinical manufacturing requires more than increasing batch size. The process must remain safe, reproducible, and capable of controlling quality as the scale changes.

BioDuro’s process development and manufacturing teams work together to transfer process knowledge, evaluate performance at larger scale, and address potential issues before GMP production. This connected approach helps maintain continuity as programs move from laboratory development into kilo lab and pilot-scale operations.

GMP and non-GMP kilo lab production
Pilot-scale API manufacturing
Process scale-up and technology transfer
Process optimization and characterization
Impurity-profile development and control
Material generation for GLP toxicology studies
GMP API production for Phase I and Phase II programs
Integrated analytical support

Process chemistry support can include optimization, characterization, and control strategies for genotoxic impurities, heavy metals, and residual solvents.

Since 2020, the Shanghai site has completed regulatory inspections by global authorities including the FDA, EMA, NMPA, and TGA.

Kilo Lab and Pilot-Scale Infrastructure

Located in Shanghai, BioDuro’s API kilo lab operations connect process development with early clinical manufacturing. Dedicated production lines, GMP kilo lab reactors, and integrated quality systems provide the flexibility needed to handle changing batch requirements while maintaining process and quality oversight.

Kilo Lab Capacity

9 GMP kilo lab reactors
GMP and non-GMP production
Material supply for toxicology and early clinical programs

Pilot-Scale Operations

6 production lines
Class D clean rooms
Process scale-up and technology transfer
Preparation for downstream GMP manufacturing

Quality and Regulatory Readiness

Integrated analytical and quality support
Established regulatory inspection history
Operations supporting Phase I and Phase II programs

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Related Drug Substance Services

Kilo lab and pilot-scale activities are closely connected to other drug substance development and manufacturing functions, helping programs progress from process development through clinical and commercial production.

Peptide Process R&D QA & EHS RSM and Intermediates High Potency API GMP API Manufacturing API Manufacturing Drug Substance Manufacturing Pre-formulation Formulation Development Stability Studies QC Testing & Release Route Scouting & Optimization Process Safety Assessment Preparative Purification Capacity Peptide Chemistry Sugar Chemistry Flow Chemistry Process R&D

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